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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus  who have inadequate glycemic control with diet and exercise.

Evaluate efficacy and safety in Japanese subjects with Type 2 diabetes mellitus

Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg  oral dose

Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose

Matching placebo for Dapagliflozin 5mg/10mg oral dose

D1692C00006_Clinical_Study_Protocol_and_Amendment

Research Site

A 24-week randomised, double-blind, parallel-group, multi-centre, placebo-controlled phase III trial to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes who have inadequate glycemic control with diet and exercise

To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. Each pair wise treatment group comparison is tested at a significance level of approximately 0.027, according to Dunnett’s method, in order to maintain an overall Type I error rate <0.050 for the primary objective. Analysis of change in HbA1c from baseline to Week 24 (LOCF) is based on ANCOVA model with treatment group and gender as fixed effects and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: 5mg: -0.35 (-0.52, -0.18), p<0.0001; 10mg: -0.39 (-0.56, -0.23), p<0.0001.

Age Continuous

Age, Customized

Gender, Male/Female

Region of Enrollment

Body Weight

Study Specific Characteristic

Body Mass Index

Seated Systolic Blood Pressure

HbA1c

Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind treatment period. 

For participants who did not complete 24 weeks LOCF (last observation carried forward) was used. Only values prior to rescue medication were used for outcome measures except for total body weight which was evaluated regardless of rescue.

To compare change from baseline in HbA1c achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0 (with alpha = 0.027 applying Dunnett's adjustment, two-sided)

Full Analysis Set, participants with non-missing baseline and Week 24 (LOCF) values

Adjusted mean change in HbA1c levels

To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

The null hypothesis is given as H0: mean(treat) minus mean(placebo) = 0 versus HA: mean(treat) minus mean(placebo) =/= 0

Adjusted mean change in Fasting Plasma Glucose (FPG)

To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment.

Adjusted mean change in body weight

Overall Study

Wash-out period was applicable only for participants with ongoing anti-diabetic treatment at enrolment. Drug-naive participants skip the period and directly proceed to a placebo lead-in period.

Eva Johnsson

To compare the change from baseline in fasting plasma glucose (FPG) achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. If p-value for primary endpoint significant, key secondary endpoints are tested following a hierarchical closed testing procedure. Analysis of change in FPG from baseline to Week 24 (LOCF) is based on ANCOVA model with treatment group and stratum (HbA1c at randomization by gender) as fixed effects and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: 5mg: -14.4 (-20.1, -8.7), p<0.0001, 10mg: -19.5 (-25.2, -13.8), p<0.0001.

To compare the change from baseline in total body weight achieved with each dose of dapagliflozin versus placebo after 24 weeks double-blind treatment. If p-value for primary endpoint significant, key secondary endpoints are tested following a hierarchical closed testing procedure. Analysis of change in total body weight from baseline to Week 24 (LOCF) is based on ANCOVA model with treatment group and stratum (HbA1c at randomization by gender) as fixed effects and baseline value as covariate. Outcome measure type Least Squares Mean represents adjusted mean change from baseline. Difference from placebo: 5mg: -1.29 (-1.98, -0.59), p=0.0003, 10mg: -1.38 (-2.08, -0.69), p=0.0001.

Arms	Assigned Interventions
Experimental: 1 Dapagliflozin 5 mg	Drug: Dapagliflozin Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
Experimental: 2 Dapagliflozin 10 mg	Drug: Dapagliflozin Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
Placebo Comparator: 3	Drug: Placebo Matching placebo for Dapagliflozin 5mg/10mg oral dose

Evaluate efficacy and safety in Japanese subjects with Type 2 diabetes mellitus

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=298&filename=CSR-D1692C00006.pdf

CSR-D1692C00006.pdf

D1692C00006_Clinical_Study_Protocol_and_Amendment

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator